Yu-Jin Kwon1,2,3, Hyangkyu Lee4, Chung Mo Nam5, Hyuk-Jae Chang6, Young-Ran Yoon7, Hye Sun Lee8, Ji-Won Lee1. 1. Department of Family Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea. 2. Department of Medicine, Graduate School of Yonsei University College of Medicine, Seoul, Republic of Korea. 3. Department of Family Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea. 4. Yonsei University College of Nursing, Mo-Im Kim Nursing Research Institute, Seoul, Republic of Korea. 5. Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. 6. Department of Internal Medicine, Division of Cardiology, Severance Cardiovascular Hosp, Yonsei University College of Medicine, Seoul, Republic of Korea. 7. Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea. 8. Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul, Republic of Korea.
Abstract
BACKGROUND: In clinical practice, concomitant treatment of orlistat with phentermine is commonly used off-label. However, clinical trials have not been performed to evaluate whether their combination improves metabolic parameters and cardiovascular risk factors other than weight loss. Therefore, we aimed to compare the efficacy of concomitant administration of orlistat and phentermine versus phentermine alone on the endothelial cell function in overweight and obese adults with back pain. METHODS: We conducted a 12-week, double-blinded, placebo-controlled clinical trial involving 114 patients with a body mass index of ≥30 (obese) or ≥27 (overweight) with weight-related comorbidities. We randomly assigned patients in a 1:1 ratio to receive orlistat (120mg) three times daily and phentermine (37.5mg) once daily, or a placebo three times daily and phentermine (37.5mg) once daily. Primary endpoint was changes in endothelium-dependent vasodilatation measured using ultrasound assessment of flow-mediated dilatation (FMD). Differences within groups after intervention were compared using the paired t-test or Wilcoxon signed-rank test. Differences in changes between the groups were calculated using an analysis of covariance after adjusting for each baseline value. RESULTS: Mean weight loss during the 12-week study period was 6.1kg in the orlistat/phentermine group and in the placebo/phentermine group. Adjusted mean changes in total and non-high-density lipoprotein cholesterol were significantly greater in the orlistat/phentermine group than in the placebo/phentermine group. Adjusted mean changes in endothelium-dependent FMD were significantly greater in the orlistat/phentermine group than in the placebo/phentermine group (4.97±0.98% vs 2.05±0.99%, respectively; p=0.038). Changes in endothelium-independent nitroglycerin-mediated dilatation were not significantly different between the groups. CONCLUSION: Orlistat/phentermine significantly improved the vascular endothelial cell function compared with phentermine alone. Orlistat might have beneficial effects on the decrease of the risk of cardiovascular disease, especially in overweight and obese patients with comorbidities. TRIAL REGISTRATION: ClinicalTrails.gov number, NCT03675191.
BACKGROUND: In clinical practice, concomitant treatment of orlistat with phentermine is commonly used off-label. However, clinical trials have not been performed to evaluate whether their combination improves metabolic parameters and cardiovascular risk factors other than weight loss. Therefore, we aimed to compare the efficacy of concomitant administration of orlistat and phentermine versus phentermine alone on the endothelial cell function in overweight and obese adults with back pain. METHODS: We conducted a 12-week, double-blinded, placebo-controlled clinical trial involving 114 patients with a body mass index of ≥30 (obese) or ≥27 (overweight) with weight-related comorbidities. We randomly assigned patients in a 1:1 ratio to receive orlistat (120mg) three times daily and phentermine (37.5mg) once daily, or a placebo three times daily and phentermine (37.5mg) once daily. Primary endpoint was changes in endothelium-dependent vasodilatation measured using ultrasound assessment of flow-mediated dilatation (FMD). Differences within groups after intervention were compared using the paired t-test or Wilcoxon signed-rank test. Differences in changes between the groups were calculated using an analysis of covariance after adjusting for each baseline value. RESULTS: Mean weight loss during the 12-week study period was 6.1kg in the orlistat/phentermine group and in the placebo/phentermine group. Adjusted mean changes in total and non-high-density lipoprotein cholesterol were significantly greater in the orlistat/phentermine group than in the placebo/phentermine group. Adjusted mean changes in endothelium-dependent FMD were significantly greater in the orlistat/phentermine group than in the placebo/phentermine group (4.97±0.98% vs 2.05±0.99%, respectively; p=0.038). Changes in endothelium-independent nitroglycerin-mediated dilatation were not significantly different between the groups. CONCLUSION: Orlistat/phentermine significantly improved the vascular endothelial cell function compared with phentermine alone. Orlistat might have beneficial effects on the decrease of the risk of cardiovascular disease, especially in overweight and obese patients with comorbidities. TRIAL REGISTRATION: ClinicalTrails.gov number, NCT03675191.
Authors: Mary C Corretti; Todd J Anderson; Emelia J Benjamin; David Celermajer; Francois Charbonneau; Mark A Creager; John Deanfield; Helmut Drexler; Marie Gerhard-Herman; David Herrington; Patrick Vallance; Joseph Vita; Robert Vogel Journal: J Am Coll Cardiol Date: 2002-01-16 Impact factor: 24.094
Authors: Ashkan Afshin; Mohammad H Forouzanfar; Marissa B Reitsma; Patrick Sur; Kara Estep; Alex Lee; Laurie Marczak; Ali H Mokdad; Maziar Moradi-Lakeh; Mohsen Naghavi; Joseph S Salama; Theo Vos; Kalkidan H Abate; Cristiana Abbafati; Muktar B Ahmed; Ziyad Al-Aly; Ala’a Alkerwi; Rajaa Al-Raddadi; Azmeraw T Amare; Alemayehu Amberbir; Adeladza K Amegah; Erfan Amini; Stephen M Amrock; Ranjit M Anjana; Johan Ärnlöv; Hamid Asayesh; Amitava Banerjee; Aleksandra Barac; Estifanos Baye; Derrick A Bennett; Addisu S Beyene; Sibhatu Biadgilign; Stan Biryukov; Espen Bjertness; Dube J Boneya; Ismael Campos-Nonato; Juan J Carrero; Pedro Cecilio; Kelly Cercy; Liliana G Ciobanu; Leslie Cornaby; Solomon A Damtew; Lalit Dandona; Rakhi Dandona; Samath D Dharmaratne; Bruce B Duncan; Babak Eshrati; Alireza Esteghamati; Valery L Feigin; João C Fernandes; Thomas Fürst; Tsegaye T Gebrehiwot; Audra Gold; Philimon N Gona; Atsushi Goto; Tesfa D Habtewold; Kokeb T Hadush; Nima Hafezi-Nejad; Simon I Hay; Masako Horino; Farhad Islami; Ritul Kamal; Amir Kasaeian; Srinivasa V Katikireddi; Andre P Kengne; Chandrasekharan N Kesavachandran; Yousef S Khader; Young-Ho Khang; Jagdish Khubchandani; Daniel Kim; Yun J Kim; Yohannes Kinfu; Soewarta Kosen; Tiffany Ku; Barthelemy Kuate Defo; G Anil Kumar; Heidi J Larson; Mall Leinsalu; Xiaofeng Liang; Stephen S Lim; Patrick Liu; Alan D Lopez; Rafael Lozano; Azeem Majeed; Reza Malekzadeh; Deborah C Malta; Mohsen Mazidi; Colm McAlinden; Stephen T McGarvey; Desalegn T Mengistu; George A Mensah; Gert B M Mensink; Haftay B Mezgebe; Erkin M Mirrakhimov; Ulrich O Mueller; Jean J Noubiap; Carla M Obermeyer; Felix A Ogbo; Mayowa O Owolabi; George C Patton; Farshad Pourmalek; Mostafa Qorbani; Anwar Rafay; Rajesh K Rai; Chhabi L Ranabhat; Nikolas Reinig; Saeid Safiri; Joshua A Salomon; Juan R Sanabria; Itamar S Santos; Benn Sartorius; Monika Sawhney; Josef Schmidhuber; Aletta E Schutte; Maria I Schmidt; Sadaf G Sepanlou; Moretza Shamsizadeh; Sara Sheikhbahaei; Min-Jeong Shin; Rahman Shiri; Ivy Shiue; Hirbo S Roba; Diego A S Silva; Jonathan I Silverberg; Jasvinder A Singh; Saverio Stranges; Soumya Swaminathan; Rafael Tabarés-Seisdedos; Fentaw Tadese; Bemnet A Tedla; Balewgizie S Tegegne; Abdullah S Terkawi; J S Thakur; Marcello Tonelli; Roman Topor-Madry; Stefanos Tyrovolas; Kingsley N Ukwaja; Olalekan A Uthman; Masoud Vaezghasemi; Tommi Vasankari; Vasiliy V Vlassov; Stein E Vollset; Elisabete Weiderpass; Andrea Werdecker; Joshua Wesana; Ronny Westerman; Yuichiro Yano; Naohiro Yonemoto; Gerald Yonga; Zoubida Zaidi; Zerihun M Zenebe; Ben Zipkin; Christopher J L Murray Journal: N Engl J Med Date: 2017-06-12 Impact factor: 91.245